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For data return, the time is ripe - FACILITATE

For data return, the time is ripe

Mar 14, 2024 | News

On November 29, at the Clinical Trials Europe meeting held in Barcelona, FACILITATE made a significant contribution to this important annual gathering, which for two days becomes a nexus for patients, health authorities, ethics committees, pharmaceutical companies, suppliers, non-profit organizations, and all key players in clinical research.

Johanna Blom, Professor of Psychobiology, Pediatric & Behavioral Neuroscience at the University of Modena and Reggio Emilia and the deputy coordinator of FACILITATE, delivered a compelling presentation titled “Patient Engagement from a Data and Ethical Perspective.” Her address delved into critical ethical considerations surrounding patient centricity in clinical trials, highlighting issues that hold paramount importance in the context of the IHI project, such as:

  • Developing a feedback mechanism that actively involves patients and recognizes them as crucial stakeholders within the clinical trial framework.
  • Gaining insights into the effectiveness of clinical trials from the viewpoint of the patients: what works and what fails.
  • Evaluating the ethical implications of the clinical trials community making decisions for patients, possibly overstepping their autonomy.

After outlining the project’s structure, leadership, and objectives, Dr. Blom detailed how, in its initial two years, the FACILITATE consortium sought to implement an innovative approach for returning data to study participants by creating an integrated cohesive legal-ethical framework.

This approach prioritized direct engagement with participants to gauge their needs for feeling secure in a trustworthy environment. To this end, the consortium leveraged its vast collective resources and networks, assembling a wide-ranging group of stakeholders. The group included patients, healthcare providers, software engineers, clinical trial data specialists, ethicists, legal professionals, and regulatory bodies.

The inclusive strategy of FACILITATE prompted a detailed discussion on data mobility, not only securing consent for returning individual clinical trial data to participants but also sparking conversations on the further use and incorporation of clinical trial data with data from other sources, such as Real-World Evidence (RWE) collected from various platforms and devices. Dr. Blom wrapped up by highlighting FACILITATE’s role as a groundbreaking chance to refine regulatory frameworks through a better comprehension of disease mechanisms and the evaluation of medical products’ effectiveness within the healthcare system. She stressed the importance of finding a harmonious balance among patient-focused approaches, emerging technologies, and regulatory mandates to advance European clinical research.

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